• 无工作经验
  • 硕士
  • 招若干人
  • 11-09 发布

职位描述

职位描述: Design, execute and evaluate lab scale experiments in order to develop robust processes for GMP manufacturing. Execute basic analytical assay if necessary.-Execute non-GMP pilot scale purification process for supplying pre-clinic trial material.-Well communicated with upstream and QC/QA to cooperate to write and review the development reports, validation protocols and reports.-Lead or participates as a purification representative in inter-departmental teams and senior management meetings-Demonstrate ability and experience in managing groups of people. Motivates and supports the career development and technical expertise of reports. Regularly meets with, sets clear goals and expectations, and provides timely feedback to reports. Hires the best people available.-Understand procurement process in the process development lab-Review data and lab books-Monitor raw material ordering and equipment maintenance schedule and its calibration-Master or above degree in life science in biochemistry, biology, or chemical engineering or related fields-At least 3 years experiences in purification process development including familiarity with process of chromatography, filtration and manufacturing operations-An understanding of cGMP requirements and their application to development and operations is desirable-Familiar with the essential protein analytical tools likes: HPLC, SDS-PAGE, ELISA, Western, protein assay …, etc.-Know why and when to use different tools to facilitate process development to differentiate QC data-Effective communicator of ideas, project goals and results-Be creative and motivated设计、实施并评估实验室规模实验便于建立稳定的工艺用于GMP生产。若有需要,能单独完成基础的分析实验。能完成非GMP中试纯化,为临床前实验提供样品材料。能同上游部门良好的沟通交流,与QC/QA合作书写及检查工艺开发报告、验证协议及报告。组织或作为纯化部门代表参与各部门间召开的会议及高管会议。具有管理团队的能力及经验。积极支持、拥护上级领导的职业规划及技术理论,定期与领导会面、制定清晰的工作目标及预期结果,并定时向领导进行反馈熟悉工艺开发实验室的采购流程。检查实验数据及记录。跟踪原辅料订单状况及负责设备维护、校正计划安排。生物化学、生物学或化学工程及相关专业硕士及以上。在纯化工艺开发领域至少三年经验,熟悉层析工艺、过滤及生产相关操作。理解cGMP相关要求并能实时运用于工艺开发***。熟练掌握重要的蛋白分析技术,如HPLC、SDS-PAGE、ELISA、Western、蛋白鉴定等。理解并能适时运用不同的QC分析数据帮组工艺开发。积极有效地同上级交流自己的想法、计划目标及结果。对工作充满创意并富于激情。 职能类别: 生物工程/生物制药

联系方式

上海市浦东张江高科技园区哈雷路998号

公司信息

ShangPharma, the holding company of Shanghai ChemPartner Co. Ltd. and Shanghai ChemExplorer Co. Ltd., is one of the largest CROs (Contract Research Organizations) in China and provides a comprehensive portfolio of services to global pharmaceutical and biotech companies. We have a team of skilled scientists and a problem-solving culture that enable us to respond to our clients' toughest challenges. Headquartered in Zhangjiang Hi-Tech Park, Pudong New Area of Shanghai, ShangPharma currently has a staff of more than 1,600 scientists in virtually every discipline. Over 40% of our scientific staff have post-graduate degrees and all of our top scientific leaders have U.S. and/or European industrial experience in major international pharmaceutical and biotechnology companies. ShangPharma---- Meeting Your Demands With a commitment to meeting your demands, ShangPharma offers unparalleled expertise, experience, and results. ShangPharma understands the rapidly changing challenges which face pharmaceutical and biotechnology companies of all sizes in developing innovative drugs. Our CRO business is built around your demands, our integrated services are designed to help bring your new products to market as safely, efficiently, and cost-effectively as possible. 尚华医药研发服务集团(SHP)旗下拥有上海睿智,上海开拓者,上海凯惠和成都凯惠四家子公司。2007年10月,TPG向尚华医药投资逾3000万美元。公司目前主要从事为国内外客户提供组合化学、药物化学、合成化学等领域的科研服务;化工医药产品质量测试;医药生物技术引进、孵化以及成果产业化等业务。2010年10月19日尚华医药登陆纽交所。 睿智化学 2003 年 4 月成立于中国药谷——上海张江高科技园区生物医药基地内,目前已拥有 13000 平方米的具备先进科研设备的国际领先标准的化学实验室。公司汇集了超过 600 人的来自海内外的精英队伍。公司的科研管理团队均由具十几年海外工作经验的博士组成,研究人员均在大型企业集团及科研院所从事多年研究与开发的高级人才,具有丰富的科研经验和创新意识。睿智化学以其先进的技术优势、具有竞争力的人才优势、以及完善的客户服务管理已经和众多 全球排名前 20 位的生物及制药企业展开 多层次的富有成效的 科研合作,成果斐然。 开拓者化学 2002 年 6 月成立于中国药谷——上海张江高科技园区生物医药基地内,通过与世界 500 强公司之一的美国礼来公司签署长期合作协议,双方共同在张江建立了礼来在中国最大的协作研究基地——开拓者化学。这种创新的合作模式为公司积累了丰富的研究经验,培养了高素质的科研队伍和高效率的科研平台。使公司在短时间内达到实验室面积 13000 多平米,研发及管理团队 300 多人 。 目前, 开拓者化学 的研发项目已经纳入到礼来的全球药品研发体系中,进而促进了中国参与全球药品研发领域的发展。 上海凯惠医药化工有限公司是专业从事医药化工及医药中间体研发、生产、销售三位一体的综合性企业,拥有近 3000 平方米的工厂基地。设备先进、配套设施齐全的 60000 平方米新厂区将于 2009 年建成投入使用。公司主要从事高附加值新型医药中间体的研发以及工艺优化,精细化工以及原料药合成的研发和工艺优化,特别致力于天然产物、新药研发所需的特种试剂、以及各种糖类化合物放大与生产。

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